Marked Heterogeneity in the Diagnosis of Compensated Cirrhosis in Chronic HCV

The determination of cirrhosis varies widely among institutions and hepatologists, as well as the severity of liver fibrosis in patients with compensated cirrhosis and those without cirrhosis, according to the results of a study published in the Journal of Gastroenterology and Hepatology.

Cirrhosis is an important factor for the management of patients with chronic hepatitis C virus (HCV) infection, specifically when deciding treatment duration with a direct-acting antiviral (DAA) regimen of glecaprevir and pibrentasvir. The American Association for the Study of Liver Disease and the Infectious Disease Society of America recommend an 8-week treatment with glecaprevir and pibrentasvir for patients with HCV without cirrhosis and a 12-week treatment with the same regimen for those with cirrhosis. However, determination of whether compensated cirrhosis is present ultimately depends on the discretion of the attending hepatologist, and it is unclear whether cirrhosis is diagnosed homogeneously in all HCV patients.

Therefore, researchers investigated the real-world diagnosis of cirrhosis by characterizing DAA-naïve patients who underwent a 12-week glecaprevir and pibrentasvir regimen in whom cirrhosis was diagnosed and compared their characteristics with those of patients who underwent an 8-week regimen in whom cirrhosis was absent. A total of 977 patients were analyzed and 296 (30.3%) were determined to have cirrhosis and received a 12-week regimen; 681 patients were determined not to have cirrhosis and received an 8-week regimen.

Results demonstrated that 2 of 27 institutions determined patients had cirrhosis, and were thus indicated to receive a 12-week regimen, via liver biopsy. Ultrasonic elastography was used at 15 institutions, and magnetic resonance elastography was used at 2. Cirrhosis was diagnosed on the basis of solely imaging (B-mode ultrasonography, computed tomography, endoscopy) and laboratory data at 11 institutions.

The researchers found that some patient characteristics largely overlapped between the 2 groups, including liver fibrosis indices and liver function enzymes. Propensity score matching demonstrated no differences in virologic efficacy, including sustained virologic response rates, between the 2 groups.

“In summary, in the real-world settings examined, the determination of cirrhosis varied widely among institutions depending on the discretion of attending hepatologist and the characteristics including severity of liver fibrosis were markedly heterogeneous; the degree of liver fibrosis overlapped significantly between patients with compensated cirrhosis and those without,” concluded the authors.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Toyoda H, Atsukawa M, Watanabe T, et al. Marked heterogeneity in the diagnosis of compensated cirrhosis of patients with chronic HCV infection in a real-world setting: a large, multicenter study from Japan. [published online January 16, 2020]. J Gastroenterol Hepatol. doi: 10.1111/jgh.14982